The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition

Federico II University

Status: Enrolling

Conditions: Breastfeeding

Treatments: Other: Data and breast milk samples collection

Study type: Observational

Funder types: Other

Identifiers

NCT06152835

14/2023

Details and patient eligibility

About

Breast milk is considered the gold standard for infant nutrition thanks to its ability to provide adequate nutrition and a high amount of protective factors for the baby's health. According to the guidelines of the World Health Organization (WHO), exclusive feeding with breast milk should be conducted until the end of 6 months of life and should be continued in the following months with the simultaneous introduction of complementary foods. Several evidence demonstrates that breast milk intake is associated with positive health outcomes, both during infancy and later in the life. Given the protective role of breast milk for the health of the child and the future adult, studying its content is of fundamental importance to have an integrated vision of the biological effects of its components on the child health, and of the factors that are able to modulate its composition. The "Building a Deeper Knowledge on Breast Milk Composition" (BuKoBc) project was designed to study the content of human milk in its entirety and at different times during the feeding and day, also in relation to environmental factors capable of modulating its composition. The results of this study may provide data on optimal reference ranges for nutrient intake in breastfed infants and may provide guidance for defining optimal nutrient intake for infants who cannot be breastfed. Furthermore, the in-depth study of the environmental factors capable of influencing the composition of breast milk will allow the development of nutritional intervention strategies for the breastfeeding mother in order to positively modulate the composition of her milk.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Italian women aged between 20 and 40 years who exclusively breastfeed children born at term from normal pregnancy
• Written informed consent

Exclusion criteria

• Non-Italian women;
• Age <20 and >40 years;
• Mothers of children born preterm;
• Non-exclusive breastfeeding;
• Mothers suffering from chronic diseases:
• malignancies;
• immunodeficiencies;
• chronic infections;
• autoimmune diseases;
• chronic inflammatory intestinal diseases;
• celiac disease;
• genetic-metabolic diseases;
• cystic fibrosis;
• chronic lung diseases;
• malformations of the cardiovascular/respiratory/gastrointestinal system;
• neuropsychiatric disorders;
• neurological diseases.

Trial design

100 participants in 1 patient group

Breastfeeding Italian women

Description:

Italian women, aged 20-40 years who breastfeed children born at full term

Treatment:

Other: Data and breast milk samples collection